Homebased Medication Review: evaluation of homebased medication review by community pharmacists in elderly people: a randomised controlled trial

ISRCTN	ISRCTN03155973
DOI	https://doi.org/10.1186/ISRCTN03155973
Protocol serial number	NTR1036
Sponsor	Lloyds Apotheken (The Netherlands)
Funders	AstraZeneca (The Netherlands), Menzis Healthcare Insurance (Menzis Zorgverzekeraar) (The Netherlands), Lloyds Apotheken (The Netherlands), Achmea (The Netherlands), Royal Dutch Pharmaceutical Society (Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie [KNMP]) (The Netherlands)

Submission date: 05/09/2007
Registration date: 05/09/2007
Last edited: 17/09/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr A. Faber
Scientific

SIR Institute for Pharmacy Practice and Policy
Leiden
2331 JE
Netherlands

Phone	+31 (0)71 576 6157
Email	a.faber@stevenshof.nl

Study information

Primary study design	Interventional
Study design	Multicentre, randomised, placebo-controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	An home-based medication review intervention conducted by a community pharmacists in close collaboration with the General Practitioner (GP) and patient improves the quality of pharmacotherapy in elderly patients.
Ethics approval(s)	Ethics approval received from the Medical Ethics Board of UMC Utrecht (University Medical Centre in Utrecht) (The Netherlands) on the 7th August 2007 (ref: 07-120/E; CCMO no.: 16412.041.07).
Health condition(s) or problem(s) studied	Home-based medication review
Intervention	A medication review will be performed by the patients pharmacist, using the medication list and GP clinical records. The medication review is evaluated and, if necessary, completed by an independent pharmacist panel. All potential drug related problems are identified and classified. The pharmacist visits the patient at home for an interview about the patient's medicines and to identify other possible drug related problems. The medication review will be completed using the information from the patient's interview. Adjustments in pharmacotherapy will be proposed and discussed with the patients GP. A treatment plan will be formulated. The GP or pharmacist will discuss the treatment plan with the patient. Patients in the control group receive regular care.
Intervention type	Other
Primary outcome measure(s)	1. The number of drug related problems per patient 2. The number of patients achieving target levels concerning blood pressure, cholesterol and HbA1C Outcomes will be measured at baseline (t = 0), and after 6 and 12 months after the intervention.
Key secondary outcome measure(s)	1. The number of patient being treated optimally according to clinical guidelines 2. The number of medicines per patient 3. The number unplanned hospital admissions 4. Change in mean values for HBA1C, cholesterol level and/or blood pressure 5. Quality of life 6. Satisfaction of GPs, pharmacists and patient with the intervention 7. The capability of pharmacists to perform a comprehensive medication review Outcomes will be measured at baseline (t = 0), and after 6 and 12 months after the intervention.
Completion date	01/09/2009

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	400
Key inclusion criteria	1. Persons aged 65 years or older 2. Prescribed five or more regular medicines, including at least one cardiovascular or anti-diabetic drug
Key exclusion criteria	Persons receiving repeat prescriptions solely from a specialist.
Date of first enrolment	01/09/2007
Date of final enrolment	01/09/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

SIR Institute for Pharmacy Practice and Policy

Leiden
2331 JE
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan